EMA post-authorisation safety study of influenza vaccine


The European Medicines Agency (EMA) has set out new requirements for influenza vaccine safety surveillance that all Marketing Authorisation Holders (MAHs) providing vaccines in the EU must address. The proposed study represents a pilot to explore the use of routinely collected data in the UK to provide timely and usefull link levitra alternative relevant information on influenza vaccine safety. UK primary care is highly computerised, though the major suppliers have different data models, coding systems, and methods of data access. Thus, a database approach may not be sufficient to meet the http://www.lipnocentrum.cz/viagra-for-sale-without-a-prescription EMA commitment. As such, a sub-study will explore the utility of active solicitation of safety data from vaccinated subjects.


To conduct a pilot assessing adverse event of cheap cialis from india interest (AEI) frequencies among flu-vaccinated subjects using routinely collected data in nine primary care practices. Our primary surveillance is of 7-day AEI, but we will not exclude events recorded outside this window, which will be analysed separately. Three practices will take part in the active surveillance sub-study. 


We will recruit nine practices representing urban and rural localities across England, and the three major computerised medical record (CMR) suppliers in the UK. 

We will extract weekly data, using a method Surrey developed for use in the national surveillance system, to allow passive observation of data; refreshed weekly from participating practices. We will evaluate 7-day AEI frequencies from this data. In three of these nine practices, we will also utilize a more active data collection approach. 

This protocol will be submitted to the NHS Research Ethics Committee (REC) for guidance on the necessary approvals for this surveillance, the consent required from patients and their carers, and the access to and use of data for this surveillance.   

Expected outcomes:

Weekly data flow that captures

o   Vaccination coverage by age strata and brand

o   Proportions of patients reporting pre-specified AEIs by age strata and brand

o   An assessment of data completeness and timeliness

This is a pilot study, the results of which will be used to assess the whether the data collected in the study meet the requirements of buy propecia and proscar enhanced safety surveillance as stipulated in the interim guidance issued by EMA in April 2014.  

Project documents:

Study Protocol 

  gsklogo-2101418       emalogo-8437184